NCT03574948

5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores

Multicentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue Scores

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This placebo cross-over trial aims to study the effect of the oral intake of an essential amino-acid 5-OH tryptophan, the precursor of serotonin, on the fatigue scores in IBD patients in deep clinical and biological remission.

Conditions

• Crohn Disease
• Ulcerative Colitis
• Fatigue
• Remission

Interventions

Type	Name	Description
DRUG	5-HTP	8 weeks active substance 5-HTP (2 x 100mg per day)
DRUG	Placebo oral capsule	8 weeks placebo (2 x 1 caps per day)

Timeline

• Start date: 2018-12-06
• Primary completion: 2021-02-23
• Completion: 2021-03-03
• First posted: 2018-07-02
• Last updated: 2021-05-18

Locations

13 sites across 1 country: Belgium